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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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EMA Holds Final Round of Testing Before New Electronic Forms are Required

The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015.

Background

In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications.

EMA began using electronic application forms for marketing authorization applications following a pilot launched in March 2012.

Currently, both paper and electronic application forms are accepted in the EU. However, in October 2014, the EU Telematics Management Board’s adopted the Heads of Medicines Agencies’ eSubmission Roadmap, which makes the case for transitioning to electronic-only application forms and lays out a timeline for the transition.

According to EMA, transitioning to new, PDF-based eAFs will provide numerous benefits, including:

"Removal of manual data extraction processes

Possibility to import data into databases

Higher data quality due to more structured data entry and usage of controlled terms

Built in business validation rules guide the applicants to fill in the forms correctly

Eventually, the goal of the eSubmissionRoadmap is to develop a single EU-wide submission portal that is fully integrated with the new eAFs by 2018.

User Testing

When EMA announced the transition to eAFs in February, the agency opened a user-acceptance testing period that ran until 5 March 2015.

Since then, EMA says the eAFs "have been significantly amended following feedback received," and that an updated version will be made available for the current round of testing.

Companies are invited to participate in the user-acceptance testing by contacting EMA to receive a test package. EMA requests companies that are part of trade associations provide their feedback directly to the association so feedback can be consolidated and submitted by the 8 June deadline. Additionally, national regulators are invited to participate and provide comment by 12 June.